Biosimilars Market Research Report - Forecast to 2029 (Includes Business Impact of COVID-19)

                                          
Abstract, Snapshot, Market Analysis & Market Definition: Biosimilars Market

Industry / Sector Trends

Biosimilars Market size was valued at USD 10.0 billion in 2018 and is expected to witness 27.0% CAGR from 2019 to 2025.

U.S.
Market Segmentation, Outlook & Regional Insights: Biosimilars Market

Biosimilars Market, By Product, 2018 & 2025 (USD Million)

The biosimilars market is poised to experience lucrative growth over the forecast period. As per a recent article, biosimilars are estimated to play a significant role in enhancing the public health issue by addressing the customer needs. The potential savings from the use of biosimilars is estimated to be around over USD 100 billion by the year 2020. Increase in demand for biosimilar drugs in order to reduce the healthcare cost will be one of the major market boosting factors.

The rising prevalence of chronic diseases across the globe, especially in developing regions owing to rise in sedentary lifestyle and increasing habit of fast food consumption will result in a growing number of people suffering from such diseases. Hence, prevalence rate in developed as well as in certain areas in developing nations will augment the demand and adoption rate of biosimilar drugs, fueling the business growth.

However, high development cost of the biosimilar drug will be one of the major reasons impeding the adoption rates in under-developed and few developing countries. As per a recent research, it takes around 7 to 8 years and costs around USD 100 million to USD 250 million to develop a biosimilar. High cost related to biosimilar drugs development will continue to hinder market growth over the forecast timeframe.

Biosimilars Market, By Product

Germany Biosimilars Market Share, By Product, 2018

Recombinant non-glycosylated proteins market held the majority market share in the year 2018 and was valued around USD 6,736.2 million. Recombinant non-glycosylated proteins include human growth hormone, granulocyte colony-stimulating factor (Filgrastim), insulin and interferon. Recent technological advancements in cell technology and high-throughput analytical techniques will help enable effective production of recombinant non-glycosylated proteins resulting in enhanced sales. Also, recent launch of insulin glargine in major countries and growing demand of filgrastim will further augment the global market growth.

Recombinant glycosylated proteins market is estimated to grow at 28.7% over the estimation period. The recombinant glycosylated proteins include erythropoietin, monoclonal antibodies , follitropin and low molecular weight heparin. Increase in number of people suffering from autoimmune diseases, chronic kidney disease and several hematological disorders such as anemia, neutropenia, etc. will lead to growing demand and adoption rate of biosimilar drugs, boosting the industry growth.

Biosimilars Market, By Application

Application of biosimilars is highest in hematology segment resulting in major market share. The hematology segment accounted for around USD 4,552.1 million revenue in the year 2018. Advancements in chemotherapy and cancer treatment has helped many patients survive, but many of the patients suffer from side-effects of chemotherapy resulting in chemotherapy-induced anemia. Increase in number of people suffering from blood disorders such as, neutropenia, anemia etc. will boost the sales of biosimilars.

Application of biosimilars in oncology segment is estimated to witness rapid growth at 37.2% over the forecast period. The recent approvals of biosimilar for cancer treatment and large number of oncology products in the pipeline will be a major market driving factor. The European Medicines Agency (EMA) approved the first oncology product in the year 2017 and number of other oncology products such as rituximab, trastuzumab and bevacizumab in the year 2018. Hence, recent oncology product approvals will augment the market growth over the estimation period.

Biosimilars Market, By Manufacturer

In-house manufacturing of biosimilars held around 75% market share in the year 2018 and was valued at USD 7,843.5 million. In-house manufacturing of the biosimilar products helps the companies to monitor and assess every step on the production and reduces other costs of delivery and shipping. Also, the flexibility and efficiency of the work provided by in-house manufacturing benefits the operational and financial capabilities of the company. Hence, currently in-house manufacturing of biosimilar products will have major market share.

Contract research and manufacturing of the biosimilars is forecasted to grow at 28.8% during the projection period. The companies in developing regions of Asia Pacific are forming strategic alliance and partnerships with big global pharma players to manufacture the biosimilars. Currently, there are few companies that give contract manufacturing of biosimilars, but recent strategic developments of the contract manufacturers and low overhead cost of manufacturing will result in growing contract manufacturing of biosimilars.

Biosimilars Market, By Technology

Development of biosimilars by recombinant DNA technology (rDNA technology) held over 80% market share and was valued at USD 8,123.6 million in the year 2018. Several biosimilar products such as human growth hormones, insulin, erythropoietin etc. are manufactured using recombinant DNA technology. The technology enhances the capability of the biosimilars to treat the disease immediately and efficiently. Hence, manufacturers use the recombinant DNA technology in order to manufacture biosimilar products.

Development of biosimilars by monoclonal antibodies (MAb) technology is forecasted to grow at 30.0% over the estimation period. Increase in number of monoclonal antibody application in treatment of cancer and autoimmune disease has resulted in growing monoclonal antibody technology adoption, fueling the business growth.

Biosimilars Market, By Region

Europe Biosimilars Market, By Country, 2025 (USD Million)

U.S. dominated the North America biosimilars market, accounting for around USD 655.6  million in the year 2018. The U.S. captured the majority market share of the North America market owing to presence of primary new technology and state-of-art facilities for biosimilar production. Also, recent biosimilar approvals by FDA in the year 2015 will result in rapid biosimilar adoption, augmenting the market growth. During the forecast years, it will witness significant growth owing to relatively low addressable needs.

India market will observe rapid growth rate of 26.7% over the forecast period. The growth is credited to rising prevalence of chronic diseases due to growing lifestyle-related habits and increase in trends of tobacco intake in millennials. Furthermore, expansion of new healthcare facilities, development of hospitals, and growing acceptance of private clinics have boosted the industry growth. Also, increase in R&D activities in the country by major player such as Biocon, Zydus Cadila etc. will boost the sales of biosimilars.

Key Players, Recent Developments & Sector Viewpoints: Biosimilars Market

Amgen, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Coherus BioSciences are some of the major industry participants operating in the global biosimilars market. These key market participants are estimated to hold significant market share owing to better R&D capabilities, strong financial position, finest quality products and strong product pipeline. These players implement several strategies in order to gain competitive advantage over its competitors. Key strategies implemented by companies in the market include novel product launches, acquisition strategy, expansion strategy, etc.

Biosimilars Industry Viewpoint

Biosimilars market is estimated to grow at a substantial rate over the estimation period owing to patent expiration of well-known and bestselling biologic drugs. Biosimilars have become common in hospitals and clinics in the developed regions of Europe. The first biosimilar was approved in Europe in the year 2006 and since then over 40 biosimilars have been approved. The Europe market is estimated to show mature growth and follow similar trend whereas recent FDA approvals in the year 2015 will lead to rapid growth of biosimilars market in the United States. In the year 2017, several biosimilars were approved across the globe and since then there has been a rapid acceleration of biosimilars demand and adoption rate thereby, fueling the business growth. Big pharmaceutical companies have made considerable investments in development of further biosimilars, and many marketing authorization applications, particularly of monoclonal antibodies, are awaiting consideration by the several regulatory authorities. Hence, recent product approvals, low cost of the biosimilar drugs, reduction in the healthcare cost, patent expiration of the major biologics and growing R&D activities of the major pharma players will lead to drive the global market growth.

INDUSTRY DEVELOPMENT:

In July 2020, Accord Healthcare S.L.U. received marketing authorization valid throughout the European Union for Zercepac(trastuzumab). Zercepac can only be used when cancer overexpresses HER2: this means that cancer produces a protein called HER2 in large quantities on the cancer cells. HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Zercepac has a highly similar structure, purity, and biological activity to Herceptin and is distributed in the body in the same way. In addition, studies in metastatic breast cancer that overexpressed HER2 have shown that the effectiveness of Zercepac infusion is equivalent to that of Herceptin infusion.

In April 2020, Shanghai Henlius Biopharmaceutical Co., Ltd. a wholly-owned subsidiary of the Company, received two Certificates of GMP Compliance of a Manufacturer from Poland€™s Chief Pharmaceutical Inspector. The Company€™s drug substance (DS) line and drug product (DP) line for HLX02 trastuzumab biosimilar at Xuhui District, Shanghai has successfully passed the Good Manufacturing Practice (GMP) on-site inspection by the EU. In May 2020, the MAA of HLX02 submitted by Accord Healthcare S.L.U. has adopted a positive opinion and recommended approval for MAA from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Key Insights Covered: Exhaustive Biosimilars Market

1. Market size (sales, revenue and growth rate) of Biosimilars industry.
2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Biosimilars industry.
3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Biosimilars industry.
4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Biosimilars industry.

Research Methodology: Biosimilars Market

  
Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request a Sample Report.
  
Demand Side Primary Contributors: OEMs, Industrial Professionals, Researches, Suppliers and Distributors, Group Purchasing Organizations, Associations, Insurers, Universities, Technological Writers, Scientists, Promoters, Investors among others.
  
Supply Side Primary Contributors: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, Regulatory Affairs Managers among others.